The Evolution Of US Sleep Care: A Sleep Physician’s Perspective
When I entered the field of sleep neuroscience and healthcare some 20+ years ago, the practice of sleep medicine was entering a new millenia, literally and figuratively. The introduction of home-based diagnostic technologies, cloud-based therapy management tools, and the broad acceptance of telemedicine across the US was all in the future, as well as the smartphone, streaming music services, and social media. The new era of sleep medicine driven by advances in medical technology has not only increased the general public’s knowledge about sleep and sleep disorders, it has spawned an entire consumer electronics industry focused on sleep optimization for performance and wellbeing, as well as direct to consumer sleep services, novel sleep healthcare products, and therapeutic programs.
With the introduction of portable sleep monitoring technology in the 1990’s, a shift from hospital and sleep laboratory care to home-based sleep care began. In an effort to keep up with the emerging sleep technology revolution, the forerunner to the American Academy of Sleep Medicine (AASM), the American Sleep Disorder Association (ASDA), developed the first practice parameters concerning portable sleep recordings in 1994 [Practice parameters for the use of portable recording in the assessment of obstructive sleep apnea. Standards of Practice Committee of the American Sleep Disorders Association. Sleep, 1994;17(4):372-7]. Following this, the proliferation of digital polysomnography (PSG) recording systems began to supplant traditional paper and pen PSG recording devices. Today, digital PSG recordings constitute the gold standard by which all other sleep testing systems are compared.
Along with the digitization of PSG waveforms and signals, automated scoring systems were introduced with capabilities to improve the detection of sleep stages, sleep-disordered breathing (SDB), and many other features of sleep architecture that occur on different time scales such as periodic breathing, epileptiform discharges, and cardiac arrhythmias. The general acceptance of digital algorithms not only improved the accuracy of sleep diagnostics but also the efficiency by which clinicians could screen and diagnose sleep disorders in an woefully underserved population.
By the mid-2000’s, multiple home sleep apnea testing devices reached the medical market in the US. Unlike prior portable sleep screening devices, this new crop of testing instruments were capable of diagnosing SDB without the need for laboratory confirmation. In response, the AASM drafted new practice parameters for the use of portable monitoring devices for adults with suspected obstructive sleep apnea (OSA) in 2003, which classified portable devices into 4 categories [Chesson AL, Berry R, Pack A., Practice parameters for the use of portable monitoring devices in the investigation of suspected obstructive sleep apnea in adults. Sleep, 2003;26(7):907-13. Initially, the AASM rejected the unattended use of portable sleep monitoring devices due to lack of evidence; however, in 2007 a “portable monitoring task force” convened by the AASM established clinical criteria for the use of portable sleep monitoring devices in diagnosing OSA in an unattended environment [Collup NA, McDowell Anderson W, Boehlecke B, Claman D, Goldberg R, Gottlieb DJ, Hudgel D, Sateia M, and Schwab R. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Journal of Clinical Sleep Medicine, 2007;3(7):737-47]. This newly published report helped usher in the current era of home sleep apnea testing (HSAT). The following year, the Center for Medicare and Medicaid Services (CMS) adopted the use of unattended HSAT in the diagnosis of OSA in its 2008 National Coverage Determination for the diagnosis and treatment of OSA [https://www.cms.gov/Medicare-Coverage-Database/view/ncd.aspx?NCDId=226&ncdver=3&NCAId=204&NcaName=Continuous+Positive+Airway+Pressure+(CPAP)+Therapy+for+Obstructive+Sleep+Apnea+(OSA)&IsPopup=y&bc=AAAAAAAAIAAA&].
Along with the shift away from sleep laboratory and hospital based testing in the 2000’s, there was another major technological advance in the treatment of SDB. Since the introduction of continuous positive airway pressure (CPAP) therapy in 1980 by Dr. Colin Sullivan, the industry of CPAP manufacturing concerned itself with making CPAP more comfortable, portable, and personalized with many different delivery variables (e.g.; bi-level PAP, heated humidification, and more comfortable interface designs). In the mid-2000’s, ResMed introduced a revolutionary auto-titrating positive airway pressure (APAP) device. For the first time, patients could take home a PAP therapy device without a sleep laboratory test to set PAP pressures at a continuous level. This auto-titrating device changed the face of sleep medicine practice as noted in the AASM practice parameters for the use of auto-titrating PAP released in 2008 []. The stage was now set for the vast majority of adult patients to be tested, diagnosed, and treated for OSA in their own homes.
As a new era of SDB testing and treatment moved care into the home, sleep laboratories and hospital-based testing programs began to suffer from a lack of reimbursement by insurers and government payers. The cost of home-based testing and treatment was set significantly lower than laboratory care, and in some states, insurers made sudden and dramatic changes to their policies related to sleep testing. Requirements to funnel all patients with suspected sleep disorders to HSAT before a laboratory sleep test could even be considered hampered progress by dictating care guidelines that were not in agreement with AASM parameters or guidelines. Just as our technological ability to test and treat SDB in the home promised to improve access for patients, financially motivated policies made sleep care more complex for physicians and patients. By the mid-2010’s sleep medicine saw reductions in much needed sleep laboratory services, a loss of sleep centers, sleep physicians, and technical staff required to perform sleep tests. In 2016, Nathaniel Watson, MD, MSc, the President of the AASM at the time, wrote an editorial in the Journal of Clinical Sleep Medicine alerting the field to a dwindling workforce in sleep medicine [Watson NF. A unified plan to strengthen the sleep medicine pipeline and maximize our workforce. Journal of Clinical Sleep Medicine, 2016;12(6):781-4]. In his article, Watson detailed a number of potential strategies to enhance the practice of sleep medicine including the recruitment of primary care physicians into “hub and spoke” working groups with sleep physicians, and advocating for additional technology to support remote sleep care and telemedicine. What was to come in 2019, namely the COVID-19 pandemic, ushered in a world-wide environment for exactly what the doctor ordered- remote technology enhanced sleep medical care.
Simultaneous with the “home-ification” of sleep healthcare was the rapid rise of sleep and activity consumer technologies. In the mid-2009, FitBit introduced a belt-worn device to count steps and movement. On the heels of the FitBit came the Jawbone UP, Nike FuelBand, Sony SmartWatch, Pebble, Samsung Galaxy Gear, LG G Watch, Motorola Moto, and many others. As consumer sleep technology grew more and more user friendly some of the major players in the current home sleep assessment marketplace such as Apple Watch, Oura Ring, Google Health, and Whoop Band emerged. In fact, Apple and Google both bought sleep technology companies (Beddit and FitBit, respectively), offically signaling the entry of Big Tech into the sleep health world. Current estimates suggest that the overall market value for sleep technology will reach $67 Billion by 2030 [https://www.globenewswire.com/en/news-release/2022/05/25/2449944/0/en/Sleep-Tech-Devices-Market-to-cross-USD-67-billion-by-2030-says-Global-Market-Insights-Inc.html]. However, the growth in consumer technology for sleep is not just concerned with monitoring. Many companies have developed software and hardware to improve sleep with pre-programmed sounds, lights, relaxation and meditation programs, cognitive-behavioral therapy-based interventions, and even FDA approved implantable devices, oral appliances, and novel therapeutics to treat OSA, insomnia, and restless legs syndrome.
As consumer sleep and wellness technology grew over the 2010’s so too did the interest from large self-insured employers in sleep-related programs to improve workplace performance, safety, and health. From trucking companies, airlines, and railroads to major manufacturers, technology giants, and government agencies, the integration of sleep health and healthcare programs into benefits plans and wellness platforms increased awareness, access, and the consumerization of sleep care. Hundreds of new “sleep” companies and products emerged in the 2010’s including sleep tracking hardware and software (i.e.; Whoop, Oura Ring, FitBit, SleepScore), direct to consumer therapies (i.e.; ChiliPad, Dreampad, multiple supplements), sleep coaching programs for parents & children (i.e.; the Batelle Sleep School, the Sleep Lady, Sleepably), integrated sleep healthcare-wellness platforms (i.e.; Vida, Optisom, SleepCharge, Rethink Care), digital therapeutics (i.e.; Sleepio, SHUTi, CBTi Coach, SleepSpace), and commercial meditation/mindfulness platforms (Calm.com, Apple Fitness, Headspace, Whil Concepts). By the end of the 2010’s self-insured employers and many forward-looking healthcare payer-provider organizations began to recognize the immediate importance of sleep for the health and safety of their populations. As a result, more and more large health claims data sets were utilized to demonstrate the financial benefits associated with treating sleep issues in high cost chronic conditions like cardiovascular disease, mental health disorders, immune/inflammatory disease, and metabolic conditions [Wickwire EM, Shaya FT, Scharf SM. Health economics of insomnia treatments: the return on investment for a good night’s sleep. Sleep Med Reviews, 2016;30:72-82; Salas RE, Kwan AB. The real burden of restless legs syndrome: clinical and economic outcomes. Am J of Managed Care, 2012;18(9):S207-12; Frost & Sullivan. Hidden health crisis costing America billions. American Academy of Sleep Medicine, 2016].
With the start of 2020, the world-wide COVID-19 pandemic was just getting started, and the practice of healthcare underwent a sea-change unlike anything seen in the previous century. Suddenly, the reliance on all sorts of technologies for communication, diagnostics, treatment, monitoring and management became the primary means of care, especially in sleep medicine. Sleep consultations, testing, and treatments moved almost entirely out of clinics, laboratories, and hospitals and into the home. Sleep testing facilities were shuttered, telemedicine platforms replaced face-to-face encounters, and technology-enabled sleep care became the new norm. Adding to the problem, the COVID-19 pandemic led to fewer sleep physicians in practice as pulmonologists, cardiologists, and many other specialists were pulled into COVID-19 care and away from routine sleep medicine care. As the pandemic continued, it became clear that sleep and mental health problems were affecting more than half of the US population with limited remote support available. Possibly in response, the FDA in the space of two years (2020-2022) cleared the first digital therapeutic for insomnia (Somryst), the first in-home polysomnography system (Nox Medical), the first surgically implanted treatment for sleep apnea (Inspire), and the first AI scoring system to determine total sleep time from a home sleep apnea test (EnsoData). Many other sleep products were also cleared by the FDA despite significant delays caused by COVID-19 and the need for rapid vaccine approvals.
One of the most novel emerging clinical technologies from this time came from a small technology start-up based in New York City, Wesper Labs. Wesper developed one of the first sleep testing and monitoring systems designed to directly measure sleep and sleep disordered breathing physiology in the home. Their patented optical respiratory effort sensing technology coupled with pulse oximetry, multiple photoplethysmography sensors, accelerometry, snore recording, and multiple algorithms for detecting sleep and wake stages, sleep-related breathing metrics, and the gold-standard sleep-disordered breathing measurements and indices, allowed clinicians for the first time to diagnose sleep-disordered breathing over multiple nights of testing. Since the Wesper Labs system does not require patients to have any specialized skills or technical sophistication to set up the device, which is driven by a smartphone app, diagnostic testing can be carried out at the convenience of the patient. After diagnosing a sleep-disordered breathing condition, clinicians have the opportunity to follow the progress of prescribed therapies using the Wesper Labs system. Because the system is rechargeable in the patient’s home, includes multiple adhesive pads for reapplication to the chest and abdomen, and does not require any apparatus on the head or neck, a sleep professional can directly monitor the effect of any type of positive airway pressure (PAP), oral appliance therapy, surgical procedure, implantable device, or medical therapy prescribed in real-time.
Prior to Wesper, all clinical decision making and sleep therapy management was done without objective sleep physiological data. Even now, most sleep professionals only have a PAP device download that algorithmically interprets variations in machine pressures as possible respiratory events over weeks and months. In some cases, patients with sleep apnea who were intolerant of PAP but also required to use it for employment reasons (i.e.; truck drivers, pilots) could falsify PAP download records through breathing on it while awake, or implementing pressure cycling machinery rather than utilizing it during sleep. More commonly, patients with poor adherence or uncontrolled apnea as indicated from a PAP download might have their therapy taken away due to insurer policies. Having the ability to record physiological sleep data in association with a tolerated and effective sleep therapy could revolutionize the personalization of sleep treatments versus continuing a one-size-fits-all approach as is currently the case with PAP. Technological innovation such as the Wesper Labs device opens the door to a new era of home sleep testing with remote sleep therapy management using day-to-day physiological outcomes, not error-prone retrospective PAP device data sets.
As noted, the application of Wesper Labs technology has many advantages for clinical care, and it also supports outcome-driven medical practice. Healthcare in the US is famously more expensive and less effective than care in other countries that have proactive and preventive healthcare strategies. Over the past decade, new models of healthcare have been launched in the US with the support of the Center for Medicare and Medicaid Services (CMS). These CMS backed “value-based” care models include Accountable Care Organization (ACO) Global and Professional Direct Contracting (GPDC) programs, ACO Realizing Equity, Access and Community Health (REACH) programs, and Medicare Advantage programs [https://innovation.cms.gov/innovation-models/aco-reach]. Value-based programs are predicated on spurring an evolution from the current fee-for-service model of care, which is highly transactional and physician-centered, to a risk-sharing payment model where patient outcomes, not physician procedures or clinical activities, determine payment. Wesper’s systems for home sleep apnea diagnostics and therapy management are well positioned to support the future of US medical care through patient-centered and value-based care models.
Evolution in the field of sleep medicine over the past thirty years has been remarkable to witness. From technological advances in sleep testing and therapies, to pandemic induced changes in medical practice and a cultural recognition of our “national sleep problem”, the opportunity for sleep professionals to integrate care into larger and more varied populations has never been better. As the speed of medical technological progress increases, the breadth of scientific discovery expands, and our ability to utilize machines and artificial intelligence in the service of health promotion continues, our society must also adapt. Currently, there needs to be a reconsideration of antiquated medical-legal practices that undermine technology-enabled patient care, restructuring of employment-based health insurance systems that limit, restrict, or outright deny care for millions of Americans, and recognition that for-profit healthcare entities, such as pharmaceutical and large scale medical device companies, need to be held responsible for the excessive costs that they inject into the US healthcare system. Without cultural reconciliation for the devastatingly unequal system of healthcare in this country, all the advances in care that we make for the few will matter not for the many.
